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Northway Biotech is expanding to the US and opening a new facility in Waltham, Greater Boston area of Massachusetts, one of the major biotechnology hubs.

By The Numbers

2014

Our journey began

>70

Happy Clients Worldwide

>100

Completed Projects

About Us

Northway Biotech is constantly looking for enthusiastic and ambitious team players who dedicate their talents to improve and produce biopharmaceuticals. Through highly skilled leadership we provide you the opportunity to use and develop your competencies to their full potential. As well as improve knowledge and skills together with inspiring colleagues.

Working at Northway Biotech means interacting with intelligent and empowered people who focus on emerging technologies that are ground-breaking, exciting, and have a positive impact on humankind. If this sounds like a place you would like to work at, we invite you to apply for one of the listed positions below. Send us your life resume and cover letter via careers@northwaybiotech.com

Vacancies

Head of Quality Assurance

Job Description

Maintaining the site's Quality system in accordance with regulatory guidelines and cGXP compliance requirements;
Maintaining the high standards of quality at the site through managing and continuously improving the effectiveness of quality processes and systems;
Developing productive and proactive relationships with regulatory bodies and customers;
Identifying, developing, and retaining qualified people to lead the implementation of quality processes;
Running an efficient and effective Quality system.

Requirements

Extensive relevant Quality experience, including quality assurance and regulatory;
Demonstrate knowledge of cGMP requirements and practices, including extensive knowledge of the EMA/EP and FDA/USP Guidance Documents for biologics;
Good understanding of pharmaceutical biotech operations and CDMO business;
University degree in natural sciences or another field of science and having knowledge in biology (microbiology, molecular biology, immunology and biotechnology), chemistry (biochemistry and analytical chemistry);
Work experience: preferably 5-7 years experience in a management role (middle management) in a biotechnology or pharmaceutical company;
Proven direct supervisory experience. Demonstrated success in supervising a team;
Possess computer skills;
Able to independently plan work and to systematize and generalize information;
Able both to independently carry out tasks and to show initiative;
Able to coordinate work, possess communication and teamwork skills;
Experienced in aligning individuals and teams to business objectives;
Experience in managing by metrics.

Senior DSP Manager

Job Description

Leading a team of 4 to 10 people by providing expertise and scientific support in the following key activities of the department: management of resources within the DSP department, mentoring the team, supervising and monitoring the progress of projects.
Driving project decision-making through timely delivery and appropriate communication across department levels and other functional departments;
Participating in TCs, F2F meetings with customers, introduction tours, representing the company’s DSP capabilities as well as providing technical information in regards to the technology of interest;
Authoring and review of high-quality documents, including reports, SOPs, process characterization documentation, and experimental protocols/reports;
DSP Tech Transfer - adapting the existing process to the manufacturing facility in regards to the equipment change, technological limitations and scale-up;
DSP process characterization and validation. Lead and manage the GMP operation of all downstream processes.

Requirements

Bachelor of Science and Master of Science degree in Natural Sciences (Molecular Biology, Biochemistry, Biotechnology, Microbiology);
7-10 years of extensive relevant DSP experience;
Hands-on and documentation experiences of DSP process development and optimization from primary recovery to locked DSP technology, including various resin-based chromatography, TFF, viral inactivation and filtration, cell lysis by chemical or mechanical methods, clarification by depth filtration and sterile filtration; protein refolding process, and final formulation;
Utilization of DSP equipment, including (AKTA, CoPrime, Cogent TFF, SoloVPE) for initial screening, process development, initial tox material generation, and GMP operation.
Application of DoE for process development/optimization to achieve higher productivity or improve product quality profile (N-Glyc, CV profiles, protein reduction/misfolding, oxidized/basic/acidic forms troubleshooting);
Understanding of stable producer cell line generation (bacterial, yeast or mammalian cell lines) and target molecule’s structure and complexity;
Experience in a Pharmaceutical Manufacturing environment- small/mid-size CDMO preferred;
Solid understanding of Biological Manufacturing processes and their regulatory requirements;
Good knowledge of operations in clean rooms;
Ability to contribute proactively and strategically, as well as ability to influence peers; Outstanding logical/analytical thinking and analysis capacities to deliver facts-based evaluations and decision-making;

Business Development Director - West Coast

Job Description

Participation in the development and implementation of key account and market strategies targeting clients that have the potential to substantially increase market share;
With the support of in-house resources, ensure alignment with manufacturing capabilities/schedules and anticipated customer needs, including the coordination of prospective client site visits as well as other opportunities;
Developing effective sales and marketing processes (market research, forecasting, client development, relationship building, pricing, proposal preparation, contract negotiation, deal closing and the handoff of contracts to Project Management);
Support the design, implementation and effectiveness of systems and processes that facilitate accurate and timely decision-making and reporting, including department and company performance (Key Performance Indicators), client financial worthiness and risk assessment/mitigation, and Customer Relationship Management;
Create marketing/competitive intelligence capability that identifies and positions the company at the forefront of key industry trends, challenges and opportunities;
Foster the development of senior-level customer relationships, including the negotiation of contract agreements that are in compliance with company systems, acting as the primary company representative;
Develop and maintain positive, constructive and trusting relationships with members of the executive leadership as well as with in-house organization;
Participate in business development meetings as required and ensure action plans and follow-up activities are completed and communicated on a timely basis;
Coordinate both internal and external technical, legal and/or financial due diligence activities for specific business opportunities;
Manage regional budget and sales pipeline, analysing and evaluating the effectiveness of business development activities, costs and results while taking corrective actions where needed;
Represent the company at various trade and industry shows, community, and/or business meetings that positively promote the company.

Requirements

At least MSc in Natural Sciences (Molecular Biology, Biochemistry, Biotechnology, Microbiology);
Experience in a Pharmaceutical Manufacturing environment, CDMO;
5-10 years of experience in Business Development Solid understanding of Biological Manufacturing processes and their regulatory requirements;
Knowledge in upstream and downstream manufacturing, as well as analytical tests and technology transfer processes;
Outstanding logical/analytical thinking and analysis capacities to deliver facts-based evaluations and decision-making;
Preferred location- West Coast

Analytical Development Senior/Principal Research Associate

Job Description

Perform development, execution, troubleshooting, and analysis of liquid chromatography based testing with minimal supervision.
Responsible for assay optimization, qualification, and validation, and technology transfer for proteins and other biomolecules.
Execute, develop, and troubleshoot assays such as ELISA, CE, gel electrophoresis and Western
Perform cell-based assays (e.g. flow cytometry) if needed.
Support upstream and downstream process development in-process testing, product release testing, and stability study testing.
Generate, manage, evaluate, and maintain data in a highly organized manner.
Coordinate with cross-functional departments on various projects.
Interpret data and contribute to technical reports.
Identify technical issues and implement solutions.
Ensure high-quality, timely documentation in laboratory notebooks and technical reports.

Requirements

BS/MS in Biochemistry, Molecular Biology, Cell Biology, Immunology, or related fields.
5 - 10 years’ of experience in the pharmaceutical industry in protein/biomolecule characterization assays and immunoassays.
Proficiency and experience in analytical techniques (HPLC, SDS-PAGE, Western etc.)
Familiarity with protein/biomolecule assay development, optimization, qualification, and validation is required.
Familiarity with CE, ELISA, LC/MS and data analysis desired but not required.
Experience with cell-based assay for release and characterization is a plus.
Familiar with statistical and data analysis tools, such as JMP, Prism etc. will be a plus.
Ability and desire to work in a fast-paced, start-up environment.
Strong collaboration, team-working, documentation, and communication skills.
Independently motivated and detail-oriented with good problem-solving ability.
Must be able to work effectively in cross-functional teams.

Quality Assurance Specialist

Job Description

Create, review, and approve documents, including standard operating procedures;
Provide metrics reporting and status updates to Quality management relating to the facility (PD lab, GMP Facility and QC);
Management of all documents, manual and electronic documents using Master Control;
Provide daily QA support for general operation activities, calibration status and preventive maintenance status of equipment and system in PD and QC laboratory and GMP Facility;
Support continuous improvement and oversight of the Quality Management System;
Assist in reviewing and approving Deviations, Out of Specification results, Environmental Monitoring Excursions, and other laboratory investigations;
Support laboratory operations (Process Development laboratory) with daily quality operational activities, such as quality management systems (QMS). This includes deviations, corrective actions, and preventive actions (CAPAs);
Assist with internal and external Auditing as required;
Review and approve protocols, data and reports relating to method validation and compendial testing;
Review and approve analytical method transfer protocols, data reports and supportive studies;
Additional responsibilities include supporting the new GMP facility and reviewing documents related to the GMP manufacturing area.

Requirements

Minimum of bachelor’s degree in Life science;
3-5 Years of relevant GMP experience in a Pharma/Biotech company, working within a quality system and regulated GMP environment;
Knowledge of cGMP/ ICH/FDA/EU regulations and guidance;
Proficient in using Microsoft applications (MS word, MS Excel, MS power point);
Strong communication Skills and ability to work well with cross-functional teams, PD, QC and Quality;
Excellent organization, written, and verbal skills.

Recruitment

Northway Biotech will process and store your personal data on your consent expressed by submitting this information. We process this data for recruitment purposes only. We will store such information until the position is open, unless you specifically agree with longer storage periods.

When evaluating your candidacy, we may address your former employers for information about your qualifications, professional skills, and business characteristics. Information from your current employer may only be collected with your consent.

If, after considering your candidacy, we will choose a candidate who is more qualified to meet our requirements, we may request your individual consent for storing your data collected at the time of selection and use it for the purpose of conducting other recruitments and contacting you accordingly.

If we obtain such consent, we will process your personal data mentioned above for no longer than two years from the date of consent. Once you have provided such consent, you are entitled to withdraw it at any time. If you exercise the right to withdraw consent, we will take actions to delete your personal data without any undue delay.

For all inquiries and complaints regarding the security and privacy of your data please contact our Data Protection Officer at careers@northwaybiotech.com